Six-Year Investigation Ends
Sale of Unapproved Drugs

Marian Segal

It looked like business was good. The Green Bay, Wisconsin,
firm had expanded its line from over 100 products in the fall
of 1985 to nearly 300 in the summer of 1989. Then, one day late
in 1992, production came to a halt by order of a consent decree
of permanent injunction prohibiting the company from manufacturing,
promoting or selling unapproved drug products.

The injunction against Enzymatic
Therapy, Inc., entered Nov. 5, 1992, followed a six-year FDA
investigation prompted by reports to the agency of serious injuries
and a death following use of so-called "nutritional supplements"
manufactured by the firm. Enzymatic Therapy signed the consent
decree without admitting to any violations of the Federal Food,
Drug, and Cosmetic Act.

From November 1984 to July 24, 1985, FDA received three consumer
complaints about Enzymatic Therapy products. One consumer claimed
she became dizzy and violently ill after taking the firm's Allernex
No. 330 capsules, purchased at a health store in Lincoln, Neb.;
another complained of tissue damage after using Dermazyme No.
101 ointment purchased from a Burien, Wash., health food store;
and the third complained of a product purported to aid hypoglycemia.,
purchased from a Cedar Rapids, Iowa, health food store.

An FDA employee posing as a customer telephoned Enzymatic Therapy
and requested information about its products. In response, the
company sent materials promoting its products. The return address
on the envelope was that of Lem's Contract Printing.

In late August and early September 1985, FDA inspected Enzymatic
Therapy and found the firm was distributing more than 100 products
it promoted for treating and preventing various diseases and conditions.
According to the investigator, Terrence J. Lemerond, founder and
president of Enzymatic Therapy, refused to provide specific product
formulations or records of product distribution, and he denied
he had any association with certain of the materials sent to the
FDA employee.

Lemerond also told the investigator he had stopped distributing
three products -- HI-BP, Raw Thyroid Complex, and L-tyrosine Thyroid
Complex-because he had been informed that FDA considered these
products illegal.

On Dec. 19, a physician in Houston reported to FDA that one
of his patients had died after taking Enzymatic Therapy's Raw
Thyroid Complex. A follow-up investigation of the Spring, Texas,
health food store where the product was purchased showed the firm
had continued to distribute Raw Thyroid Complex after Lemerond
had promised to stop.

On June 26,1986, FDA sent Lemerond a letter warning that several
of his firm's products were unapproved new drugs because they
carried unsubstantiated health claims. The letter also said the
products were misbranded because the labeling was false and misleading
and failed to bear adequate instructions for use. Further, the
letter warned that if Enzymatic Therapy continued to sell these
products, it would be subject to other regulatory actions, such
as seizure or injunction.

Lemerond's attorney responded with a letter claiming that Enzymatic
Therapy rigorously screened and monitored all labeling to ensure
its products were not misbranded and denied the firm made therapeutic
claims in its labeling.

A second warning letter sent the following month was answered
with another denial regarding the claims and specifically denying
the firm was responsible for certain promotional materials accompanying
its products.

On March 27, 1987, a Fort Smith, Ark., hospital notified FDA
of a patient who, after taking Enzymatic Therapy's Raw Thyroid
Complex, suffered an elevated thyroid level and was admitted to
intensive care. Lemerond again promised FDA to stop selling the
product.

Between January 1988 and July 1989, FDA investigators twice
more inspected Enzymatic Therapy (with Lemerond again refusing
to provide sales records of promotional materials, according to
the investigators); inspected health food stores that sold the
firm's products; and made an undercover buy from Enzymatic Therapy.

In May 1989, undercover FDA employees from the Chicago district
office attended an Enzymatic Therapy sales training seminar at
which all the participants were required to sign the following
statement:

I am not employed by any Federal, City, or State agency under
the control of the Health Department, Food and Drug Administration,
or any other governmental or consumer agency. I do not work indirectly
with any government agency. I also will not tape this seminar
for any government agency to be used against Enzymatic Therapy.

The employees signed the statement and attended lectures they
said described how the firm's products benefit the immune system
and system detoxification. They were given materials recommending
the firm's products for serious illnesses, "Health Guides"
describing the firm's products, and an order form with Lem's Contract
Printing's return address. Following a July 1989 inspection, Lemerond
and his attorney requested a meeting with FDA to discuss the inspection
findings. According to the complaint for injunction, Lemerond
admitted some of his products were illegal and made unsubstantiated
claims. He promised he would cooperate more with FDA in the future.
Two weeks later, the attorney sent FDA a letter stating that many
of the promotional materials FDA collected were being destroyed
or discontinued and that Lemerond intended to submit revised labeling
and other promotional materials to FDA for agency review. Nevertheless,
during several follow-up inspections of health food stores in
March 1990, FDA investigators collected promotional materials
containing health claims, including some identical to those Lemerond
had promised to destroy. In addition, FDA alleged that undercover
buys by FDA in April 1990 and March 1991 and another inspection
of Enzymatic Therapy provided further evidence that, despite the
firm's knowledge of serious injuries to customers following use
of its products and without regard to FDA's warnings, it continued
to promote and distribute unapproved and misbranded drugs.

In November 1992, the government and the defendants signed
a consent decree of injunction prohibiting the defendants from
manufacturing, packing, processing, distributing, selling, promoting,
labeling, or advertising its unapproved products, unless and until
FDA approves new drug applications or investigational exemptions
for the products. In addition, the decree stipulated the defendants
must:

for the next three years, submit for FDA's approval any promotional
materials, labeling or literature about its products

reimburse FDA for costs of inspections and examinations needed
to evaluate compliance with the injunction

permit FDA to inspect the defendants' facilities, the promotional
materials, labeling, food and drug products, equipment, and shipping
records, and to take samples of products and their labeling